Classical Pharmacokinetics
From the early days in 1997 onwards, Kinesis Pharma has become a preferred partner in performing pharmacokinetic (PK) analyses for many innovative pharmaceutical companies, including 3 out of the top 10 biggest pharmaceutical companies.
Within the department of clinical development, a team of well trained data analysts and report writers, supervised by experienced study directors, is committed to delivering optimal quality within agreed timeframes for each (interim) analysis. Over the last decade, large numbers of classical PK analyses have been performed, including first-in-man studies, ADME studies, interaction studies, bioequivalence studies (including statistics), studies in special populations and phase II/III studies.
As Kinesis Pharma encompasses all necessary facets in pharmaceutical development, kinesis’ experts in classical PK work in close collaboration with Kinesis’ clinical, but also non-clinical, CMC and regulatory specialists to ensure that clinical development plans provide the most time-efficient and cost-effective strategy for clients.
Ensuring high quality
In-house validated WinNonlin and SAS routines are among the programs used for calculation of the pharmacokinetic parameters (e.g. Cmax, AUC, half-life) and reporting of the data in tables and graphs.
High quality GCP based procedures will be followed, depending on the request of the sponsor. All studies are performed by competent and qualified staff, according to standard operating procedures (SOPs) using validated software. Additionally, all data and calculations are checked by an independent reviewer, before the final report is peer reviewed internally. If requested, all critical phases such as the study plan, study procedures, analysis data and the final report can be audited by our independent QA department.
PK/PD analyses and Toxicokinetics
Graphical evaluation of pharmacokinetic-pharmacodynamic relationships (PK/PD) is also part of our biometric services. Kinesis Pharma also offers population pharmacokinetic (PK), pharmacodynamic (PD) and PK/PD analyses of non-clinical and clinical studies including computer assisted trial design (CATD). Please visit our PK/PD webpage for more information.
For more information on evaluation of toxicokinetic data, please visit our PK/TK page of our non-clinical department.